Indications and uses
for the temporary relief of sore gums due to teething in children 2 years of age and older. For use in children under the age of 2, consult a physician or healthcare provider.
for the temporary relief of sore gums due to teething in children 2 years of age and older. For use in children under the age of 2, consult a physician or healthcare provider.
■ wash your hands ■ use your fingertip or cotton applicator to apply a small pea-size amount of Oral Gel and spread over gums ■ apply to affected area up to 4 times daily or as directed by a physician or healthcare provider ■ for children under 2 years of age, consult a physician or health care provider
Benzocaine 7.5%
Oral Pain Reliever
for the temporary relief of sore gums due to teething in children 2 years of age and older. For use in children under the age of 2, consult a physician or healthcare provider.
Allergy alert: do not use this product if your baby has a history of allergy to local anesthetics such as procaine, butacaine or other "caine" anesthetics
■ more than directed ■ for more than 7 days unless directed by a physician or healthcare provider
■ fever and nasal congestion are not symptoms of teething and may indicate the presence of infection. If these symptoms persist, consult your physician
sore mouth symptoms do not get better in 7 days ■ irritation, pain or redness does not go away ■ swelling, rash or fever develops
In case of overdose or allergic reaction get medical help or contact a Poison Control Center right away
■ wash your hands ■ use your fingertip or cotton applicator to apply a small pea-size amount of Oral Gel and spread over gums ■ apply to affected area up to 4 times daily or as directed by a physician or healthcare provider ■ for children under 2 years of age, consult a physician or health care provider
do not use if tube seal under cap is broken, missing or if the tube tip is cut prior to opening
cellulose gum, flavor, gelatin, mineral oil, pectin, petrolatum, polyethylene glycol, red 40, sodium saccharin
| Class | Version | Type | Effective |
|---|---|---|---|
| BENZOCAINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 47046-180-02 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-e77f-a426-e053-dadaa90af4c2 | oral gel |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 47046-180-01 | My Fair Baby oral gelInstant Pain Relief | 14 g in 1 TUBE | GEL | 14 | 1 | |
| 47046-180-02 | My Fair Baby oral gelInstant Pain Relief | 1 in 1 BOX | GEL | 1 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 47046-180 | 47046-180-01, 47046-180-02 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | IACT |
| GELATIN | 2G86QN327L | IACT |
| MINERAL OIL | T5L8T28FGP | IACT |
| PECTIN | 89NA02M4RX | IACT |
| PETROLATUM | 4T6H12BN9U | IACT |
| POLYETHYLENE GLYCOL 1000 | U076Q6Q621 | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| BENZOCAINE | U3RSY48JW5 | ACTIB |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| b6e209cb-9f9c-4cb6-e053-2995a90a947a | b6e209cf-2a60-e7e3-e053-2a95a90a64df | 2020-12-20 | Warnings | b6e209cb-9f9c-4cb6-e053-2995a90a947a b6e209cf-2a60-e7e3-e053-2a95a90a64df |
Adverse event summaries are temporarily unavailable. Other product information remains available.